NDC 65044-0777

Standardized Grass Pollen, Redtop

Standardized Grass Pollen, Redtop

Standardized Grass Pollen, Redtop is a Percutaneous; Subcutaneous Injection, Solution in the Standardized Allergenic category. It is labeled and distributed by Jubilant Hollisterstier Llc. The primary component is Agrostis Gigantea Pollen.

• Product ID: 65044-0777_0cdf6656-6263-450e-a312-5cb125444591
• NDC: 65044-0777
• Product Type: Standardized Allergenic
• Proprietary Name: Standardized Grass Pollen, Redtop
• Generic Name: Standardized Grass Pollen, Redtop
• Dosage Form: Injection, Solution
• Route of Administration: PERCUTANEOUS; SUBCUTANEOUS
• Marketing Start Date: 1998-01-15
• Marketing Category: BLA / BLA
• Application Number: BLA103876
• Labeler Name: Jubilant HollisterStier LLC
• Substance Name: AGROSTIS GIGANTEA POLLEN
• Active Ingredient Strength: 10000 [BAU]/mL
• Pharm Classes: Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 65044-0777-1

5 mL in 1 VIAL (65044-0777-1)

• Marketing Start Date: 1998-01-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 65044-0777-3 [65044077703]

Standardized Grass Pollen, Redtop INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA103876
• Product Type: STANDARDIZED ALLERGENIC
• Marketing Start Date: 1998-01-15

NDC 65044-0777-2 [65044077702]

Standardized Grass Pollen, Redtop INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA103876
• Product Type: STANDARDIZED ALLERGENIC
• Marketing Start Date: 1998-01-15

NDC 65044-0777-4 [65044077704]

Standardized Grass Pollen, Redtop INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA103876
• Product Type: STANDARDIZED ALLERGENIC
• Marketing Start Date: 1998-01-15

NDC 65044-0777-1 [65044077701]

Standardized Grass Pollen, Redtop INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA103876
• Product Type: STANDARDIZED ALLERGENIC
• Marketing Start Date: 1998-01-15

Drug Details

Active Ingredients

Ingredient	Strength
AGROSTIS GIGANTEA POLLEN	10000 [BAU]/mL

Pharmacological Class

• Standardized Pollen Allergenic Extract [EPC]
• Non-Standardized Pollen Allergenic Extract [EPC]
• Increased Histamine Release [PE]
• Cell-mediated Immunity [PE]
• Increased IgG Production [PE]
• Pollen [CS]
• Allergens [CS]

NDC Crossover Matching brand name "Standardized Grass Pollen, Redtop" or generic name "Standardized Grass Pollen, Redtop"

NDC	Brand Name	Generic Name
65044-0777	Standardized Grass Pollen, Redtop	Standardized Grass Pollen, Redtop
65044-0778	Standardized Grass Pollen, Redtop	Standardized Grass Pollen, Redtop
65044-0779	Standardized Grass Pollen, Redtop	Standardized Grass Pollen, Redtop
65044-0780	Standardized Grass Pollen, Redtop	Standardized Grass Pollen, Redtop